Barricaid ACD (Annular Closure Device)Recalls & reported problems across all models
Intrinsic Therapeutics, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 87
- Deaths reported
- 0
- Injuries reported
- 65
- Recalls
- 0
We found 2 models of Barricaid ACD (Annular Closure Device) by Intrinsic Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 87 adverse event reports in the FDA's MAUDE database, received between Jul 19, 2022 and Sep 21, 2026 — classified as 65 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Failure to Seal” (17 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Barricaid ACD (Annular Closure Device) problems
Device problems
- Adverse Event Without Identified Device or Use Problem31
- Failure to Seal17
- Migration10
- Fracture8
- Improper or Incorrect Procedure or Method8
- Malposition of Device4
- Device Appears to Trigger Rejection3
- Device Dislodged or Dislocated3
Patient problems
- Hernia26
- Vertebral Fracture15
- Limb Pain12
- No Clinical Signs, Symptoms or Conditions8
- Pain8
- Unspecified Infection7
- Insufficient Information3
- Nerve Damage3
Barricaid ACD (Annular Closure Device) models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Barricaid® ACD (Annular Closure Device) 8mm widthReherniation Reduction Device58 reports
- Barricaid® ACD (Annular Closure Device) 10mm widthReherniation Reduction Device29 reports
Recent Barricaid ACD (Annular Closure Device) adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Scar Tissue
MAUDE report 50839786 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient experienced an infection, and during a revision surgery to address the infection, the implant was removed.
Patient problems: Unspecified Infection
MAUDE report 50838812 ↗InjurySep 15, 2026Failure to Seal
On (b)(6) 2026, a distributor reported to Area Vice President that this patient had experienced a reherniation. Later, a second report was made (on (b)(6) 2026) that the patient had a revision surgery for this reherniation.
Patient problems: Hernia
MAUDE report 50775460 ↗InjuryAug 6, 2026Failure to Seal
Surgeon scheduled a re-operation for this patient due to a suspected re-herniation. Removal case was on (b)(6)2026 the device was removed prior to further surgical techniques and device was reported to be in good position.
Patient problems: Hernia
MAUDE report 50165114 ↗InjuryJul 6, 2026Failure to Seal
PATIENT REHERNIATED AND THE MESH HAD MIGRATED POSTERIORLY. THE REVISION SURGERY WAS PERFORMED (FUSION), AND THE MESH PORTION WAS REMOVED.
Patient problems: Hernia
MAUDE report 25723441 ↗MalfunctionOct 31, 2025Migration; Failure to Seal; Migration; Failure to Seal
BASED ON PERSONAL COMMUNICATION FROM A WORK COLLEAGUE, THE PATIENT HAD AXIAL BACK PAIN AND HAD MRI AND X-RAY IMAGING. THE IMAGES SHOWED MIGRATION OF THE MESH MARKER OUT OF THE DISC SPACE AND COMPRESSION OF THE NERVE ROOT DUE TO A REHERNIATION. THE PATIENT HAS ONLY HAD IMAGING PERFORMED AND HAS NOT YET HAD A FOLLOW-UP VISIT WITH THE SURGEON.
Patient problems: Back pain; Dural Tear
MAUDE report 23439498 ↗InjuryOct 23, 2025Failure to Seal; Failure to Seal
ON (B)(6) 2025 THE SURGEON PERFORMED A TOTAL DISC REPLACEMENT (TDR) AND APPROACHED ANTERIORLY. THE SURGEON DETACHED THE POLYMER OCCLUSION COMPONENT AND THEN BROKE OFF THE ANCHOR HEAD AS WELL. BOTH WERE REMOVED COMPLETELY, AND NO FRAGMENTS WERE VISUALIZED VIA X-RAY. THE VERTICAL KEEL AND BASEPLATE WERE LEFT IN THE PATIENT. NO ADVERSE PATIENT OUTCOMES WERE REPORTED. FOLLOWING UP WITH THE SURGEON, IT WAS NOTED THAT THE PATIENT EXPERIENCED RECURRENT DISC PROTRUSION AND PERSISTENT DISCOGENIC PAIN AS THE NEED FOR A TDR PROCEDURE.
Patient problems: Back pain; Limb Pain
MAUDE report 23370898 ↗InjuryOct 16, 2025Failure to Seal; Failure to Seal
THE PATIENT WAS IMPLANTED WITH A BARRICAID DEVICE ON (B)(6) 2025. THE PATIENT EXPERIENCED ANOTHER HERNIATION AT THE SAME LEVEL. THE SURGEON PERFORMED A REVISION MICRODISCECTOMY ON (B)(6) 2025 AND DID NOT REMOVE THE IMPLANT.
Patient problems: Hernia
MAUDE report 23314124 ↗InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A RE-OPERATION WAS SCHEDULED AS A REMOVAL AND RE-IMPLANTATION AT L5. THE SURGEON DETERMINED THAT SCAR TISSUE WAS PRESENT. THE IMPLANT WAS FOUND AS IMPLANTED, THE NERVE WAS MOBILIZED AND THE BARRICAID IMPLANT WAS LEFT IN PLACE.
Patient problems: Insufficient Information
MAUDE report 23020136 ↗InjurySep 8, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
A 10 MM IMPLANT WAS TO BE IMPLANTED IN L5 FOR A L5-S1 DISC HERNIATION. X-RAY SHOWED THE ANCHOR'S BASEPLATE ENTERED THE VERTEBRAL BODY AND PENETRATED THROUGH THE END PLATE INTO THE DISC SPACE. THE IMPLANT WAS REMOVED AND THERE WAS NO ATTEMPT TO IMPLANT THE OPPOSING VERTEBRAL BODY. ACCORDING TO THE REPORTER, THE SURGEON COULD NOT ACCESS THE IMPLANT WITH THE REMOVAL TOOL DUE TO THE IMPLANT'S ANGLE, AND THE SURGEON ULTIMATELY USED OSTEOTOMES TO REMOVE THE IMPLANT.
Patient problems: Vertebral Fracture
MAUDE report 22991499 ↗InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED TO INTRINSIC THAT THEY HAD A STAPH INFECTION AND UNDERWENT REVISION SURGERIES TO TREAT THE INFECTION AND ULTIMATELY HAD THE BARRICAID DEVICE REMOVED.
Patient problems: Medical device site infection
MAUDE report 22893547 ↗InjuryAug 12, 2025Failure to Seal; Failure to Seal
INTRINSIC WAS NOTIFIED THAT THE PATIENT REHERNIATED MORE THAN SIX WEEKS POST-OPERATIVELY ON (B)(6) 2025. ACCORDING TO THE SURGEON, THE HERNIATION OCCURRED NEAR THE IMPLANT, WHICH WAS REPORTED TO BE INTACT. A FUSION SURGERY WAS PERFORMED ON (B)(6) 2025, WHERE THE IMPLANT WAS PARTIALLY REMOVED TO MAKE ROOM FOR AN INTERBODY CAGE.
Patient problems: Hernia
MAUDE report 22782799 ↗InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025 (APPROX. 2 MONTHS POST IMPLANTATION), IT WAS REPORTED TO AN INTRINSIC REPRESENTATIVE THAT THE PATIENT HAD A 2ND HERNIATION AT THE INDEX LEVEL. THE DOCTOR WAS PLANNING TO PERFORM A REVISION SURGERY ON (B)(6) 2025 AND AFTER THE SURGERY THEY DECIDED TO NOT REMOVE THE BARRICAID DEVICE.
Patient problems: Hernia
MAUDE report 22719563 ↗InjuryJul 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
A PHYSICIAN REPORTED TO INTRINSIC'S EMAIL ABOUT A BARRICAID REMOVAL THEY HAD PERFORMED. THE SURGEON REPORTED THE DEVICE WAS REMOVED DUE TO "IRRITATION, NERVE DAMAGE, CAUDA EQUINA, AND POSSIBLE ALLERGY (TO DEVICE MATERIALS)".
Patient problems: Insufficient Information
MAUDE report 22532978 ↗InjuryJul 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT WAS IMPLANTED IN L5 FOR THE L5/S1 DISC SPACE. THE PATIENT CAME BACK TO SURGEON COMPLAINING OF SIMILAR SYMPTOMS PRIOR TO IMPLANTATION SURGERY. FLUID BUILD-UP WAS FOUND AROUND THE IMPLANT, SO THE PHYSICIAN DECIDED TO REMOVE THE IMPLANT AS PART OF THE TREATMENT. THE PATIENT DID NOT PRESENT ANY SYMPTOMS OF INFECTION, AND WAS REPORTED AS DIABETIC.
Patient problems: Limb Pain
MAUDE report 22519150 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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